The Effect of Orofacial Myofunctional Therapy on Neuromuscular Outcomes and Orofacial Function in Children and Adolescents in Estonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Tartu University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in normalized sEMG Area of the mylohyoid region during swallowing
Study Overview
Brief Summary
The aim of the present study is to evaluate the effects of semi-standardized myofunctional therapy on the functional and neuromuscular characteristics of the orofacial system in children and adolescents aged 7-14 years using a longitudinal study design and a unified assessment protocol. Myofunctional therapy is a treatment method for functional disorders of the oral, lingual, and facial regions. The study approaches the orofacial system holistically by linking functional characteristics with anatomical structures, including palatal morphology and skeletal and dentoalveolar occlusal relationships, while also considering the impact of treatment adherence on outcomes.
Participants' orofacial functions and neuromuscular characteristics will be assessed before, during, and after therapy using standardized clinical measurements. The study will analyze the dynamics of changes, individual variability, and associations with craniofacial phenotype and treatment adherence.
Despite the widespread use of myofunctional therapy in Estonia, systematic evidence regarding therapy effectiveness, treatment dynamics, and factors influencing outcomes is limited, and unified assessment and intervention standards are lacking. The study aims to address this knowledge gap and support evidence-based implementation of myofunctional therapy, clinical decision-making, and healthcare resource planning.
Detailed Description
This is a prospective longitudinal clinical interventional study conducted at the Department of Paediatric Dentistry, Stomatology Clinic, Tartu University Hospital, Estonia. The study will include up to 80 children and adolescents aged 7-14 years who have been referred for orofacial myofunctional therapy and meet the study eligibility criteria.
Participants will receive semi-standardized orofacial myofunctional therapy as part of their clinical treatment. The study period for each participant is approximately nine months, including an eight-month therapy intervention with eight therapy sessions conducted at intervals of approximately 4-6 weeks.
Standardized clinical assessments are performed at baseline (T0, visit 1), during therapy (T4, visit 5), and after completion of the intervention (T8, visit 9). The assessments include neuromuscular and orofacial functional measurements. Treatment adherence is assessed throughout the intervention period using standardized questionnaires completed from the perspectives of the child, parent or legal representative, and therapist.
The study also evaluates craniofacial and dentoalveolar characteristics as exploratory factors in relation to treatment response.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 7-14 years at the time of enrollment.
- •Referred for orofacial myofunctional therapy.
- •Diagnosed with an orofacial myofunctional disorder.
- •Willingness to participate in therapy and assessments according to the study protocol.
- •Written informed consent from a parent or legal guardian for the child's participation in the study.
- •Written informed assent from the child to participate in the study.
- •Written consent from a parent or legal guardian to participate in the study by completing the questionnaire assessing their child's treatment adherence.
- •Sufficient proficiency in Estonian to participate in the study and understand the study procedures.
Exclusion Criteria
- •Structural craniofacial anomalies or syndromes (e.g., cleft lip and/or palate).
- •A medical condition that prevents safe participation in therapy or study assessments.
Arms & Interventions
Orofacial Myofunctional Therapy
Participants receive semi-standardized orofacial myofunctional therapy for 8 months, with a total of 8 therapy sessions.
Intervention: Semi-standardized Orofacial Myofunctional Therapy (Behavioral)
Outcomes
Primary Outcomes
Change in normalized sEMG Area of the mylohyoid region during swallowing
Time Frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Surface electromyographic (sEMG) activity of the bilateral mylohyoid region is recorded during swallowing. The sEMG Area during swallowing is normalized to the sEMG Area recorded during maximal tongue-palate pressure using the Iowa Oral Performance Instrument (IOPI) bulb. Normalized Area (%) is calculated as: sEMG Area during swallowing / sEMG Area during maximal tongue-palate pressure × 100. Change in normalized Area is assessed across the study period.
Secondary Outcomes
- Change in tongue strength measured using the Iowa Oral Performance Instrument (IOPI)(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in lingual swallowing pressure measured using the Iowa Oral Performance Instrument (IOPI)(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in lip strength measured using the Iowa Oral Performance Instrument (IOPI)(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in tongue-to-incisive papilla opening (TIP)(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in lingual-palatal suction opening (LPS)(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in overall orofacial function assessed using a modified Orofacial Myofunctional Evaluation with Scores (OMES)(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG mean frequency of the mylohyoid region during standardized solid-food swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG mean frequency of the mylohyoid region during swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG mean power frequency of the mylohyoid region during swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG Area of the mylohyoid region during swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG mean frequency of the masseter region during swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG mean power frequency of the masseter region during swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG Area of the masseter region during swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG mean power frequency of the mylohyoid region during standardized solid-food swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG Area of the mylohyoid region during standardized solid-food swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG mean frequency of the masseter region during standardized solid-food swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG mean power frequency of the masseter region during standardized solid-food swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))
- Change in sEMG Area of the masseter region during standardized solid-food swallowing(Baseline (T0), 4 months (T4), and 8 months (T8))